[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mucosa Innovations, S.L.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":138},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,88,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100649752","retrospective-observational-study-of-oral-complications-and-quality-of-life-in-head-and-neck-cancer-patients-treated-with-radiotherapy-or-chemoradiotherapy-100649752",false,"NCT07739771","Retrospective Observational Study of Oral Complications and Quality of Life in Head and Neck Cancer Patients Treated With Radiotherapy or Chemoradiotherapy.","Retrospective Evaluation of Severe Oral Mucositis Incidence, Time to Onset and Functional Impact in Quality of Life in Head and Neck Cancer Radiated and Chemo-radiated Patients. Part of the Stop Oral Mucositis Project (STOPOMP)","Inclusion Criteria:\n\n* Adults (≥18 years) diagnosed with head and neck cancer\n* Treated with radiotherapy or chemoradiotherapy, with or without surgery and\u002For immunotherapy, according to tumor type and stage, between 2019 and 2023\n* With available medical records documenting clinical assessments of oral mucositis during at least the radiotherapy\u002FCRT treatment period, and that had used the oral mucosa topical measures\n\nExclusion Criteria:\n\n* Patients with missing or insufficient clinical records required for the study\n* Patients with concomitant malignancies undergoing active treatment at the same time.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","OBSERVATIONAL","Head and Neck cancer patients receiving radiation therapy (with or without chemotherapy) suffer several oral complications, such as oral mucositis, which impairs quality of life of patients during radiotherapy and in the post-treatment follow-up period. The use of topical agents to protect oral mucosa against radiation-induced toxicity is part of the routine clinical practice. Among these products, the use of mouthwashes and\u002For gels are extensively used in the Centro Oncológico Clara Campal - Hospital HM Sanchinarro. Once such product is a proprietary formulation based on natural ingredients such as olive oil, betaine, and xylitol (Mucosa Innovations S.L.).",[24,25,26,27,28,29,30,31],"Oral Mucositis","Quality of Life","Mucositis","Pain","Speech","Saliva","Radiation Toxicity","Chemotherapeutic Toxicity",[24,33,34,27,35,36,37,38,39],"Cancer Therapy Toxic Effect","Cancer Support","Ulcers","Treatment Interruptions","Oral Mucosa","Radiotherapy","Chemotherapy","NOT_YET_RECRUITING","2026-07-28",{"date":43,"type":44},"2026-07-31","ACTUAL",{"date":46,"type":20},"2026-08",{"date":48,"type":20},"2026-10",{"name":50,"class":51},"Mucosa Innovations, S.L.","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":65,"conditions":66,"keywords":76,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":52},"100649631","retrospective-cohort-study-of-symptoms-and-quality-of-life-in-women-with-genitourinary-syndrome-of-menopause-100649631","NCT07737782","Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.","Retrospective Observational Study in a Cohort of Postmenopausal Women With Genitourinary Syndrome of Menopause (GSM): Characterization of Symptoms and Impact on Quality of Life.","Inclusion Criteria:\n\nPatients included in this retrospective data evaluation must have met all of the following criteria:\n\n* Postmenopausal women (defined as at least 12 consecutive months of amenorrhea)\n* Present at least one symptom of GSM documented in the medical record\n* Evidence in the medical record that the patient had perceived the GSM symptom(s) as having an impact on her quality of life.\n* Documentation in the medical record that the patient had initiated treatment with XCM INTIM, together with follow-up clinical data including an assessment performed at least 8 weeks after treatment initiation.\n* Patients that had attended at the Department of Obstetrics and Gynecology of Hospital Universitario La Luz between January 2022 and April 2026, regardless of whether they had participated in another study during this period.\n\nExclusion Criteria:\n\nPatients will be excluded from the study if any of the following conditions were present:\n\n* Use of topical vulvovaginal hormonal products within 4 weeks prior to initiation of XCM INTIM treatment.\n* Use of systemic estrogen therapy within 8 weeks prior to initiation of XCM INTIM treatment.\n* Presence of relevant gynecological and\u002For urinary conditions that could have interfered with the assessment of symptoms attributed to GSM, including but not limited to active vulvovaginal and\u002For urinary tract infections, significant vulvar lesions, active gynecological malignancies, severe stress urinary incontinence (Sandvik score ≥ 8), pelvic organ prolapse stage III or higher (POP-Q), or any other condition considered by the investigator to be a significant confounding factor.\n* Previous radiotherapy involving the pelvic and\u002For genital region.\n* Previous laser and\u002For radiofrequency treatment in the pelvic region.\n* Medical records containing insufficient information for analysis of the primary study variables.","FEMALE","40 Years","75 Years",{"count":64,"type":20},100,"The goal of this clinical trial is to retrospectively identify the most prevalent symptoms of genitourinary syndrome of menopause (GSM) among postmenopausal women and to evaluate their impact on quality of life. Moreover, based on data collected from medical records and\u002For patient-reported questionnaires, if available data enable it, it will be assessed whether treatment with the topical vulvovaginal gel XCM INTIM for a minimum of 8 weeks results in changes in symptom severity and in the impact of these symptoms across different quality-of-life domains.",[67,68,69,25,70,71,72,73,74,75],"Vulvar Atrophy","Vulvovaginal Signs and Symptoms","Genitourinary Syndrome of Menopause (GSM)","Menopause Related Conditions","Dyspareunia","Urinary Incontinence, Urgency-frequency","Sexual Function","Women´s Health","Vaginal Dryness",[77,68,78,25,79,74,80],"Genitourinary Syndrome of Menopause","Patient Reported Outcome Measures","Day-to-Day Impact of Vaginal Ageing","Real World Data",{"date":82,"type":44},"2026-07-30",{"date":84,"type":20},"2026-07",{"date":86,"type":20},"2026-09",{"name":50,"class":51},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":52},"100488116","effect-of-a-novel-topical-composition-on-the-incidence-of-severe-oral-mucositis-in-head--neck-cancer-radiated-patients-and-quality-of-life-assessed-by-proms-100488116","NCT05635929","Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.","Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs. A Two Phases Study, Part of STOP OM PROJECT. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial.","STOPOMP","Inclusion Criteria:\n\nAcute Phase\n\n* Patients diagnosed with Head \\& Neck cancer who will undergo radiotherapy (with or without concomitant chemotherapy)\n* Patients who are able to read, understand, and complete the questionnaire.\n* Patients over 18 years of age.\n\nChronic Phase\n\n* Patients who have completed radiotherapy treatment at least 6 months before study enrollement.\n* Patients who are able to read, understand, and complete the questionnaire.\n* Patients over 18 years of age.\n\nExclusion Criteria:\n\nAcute Phase\n\n* Patients who are unable to properly use the products.\n* Patients who do not consent to participate in the study.\n* Patients who were being treated for another type of cancer.\n\nChronic Phase\n\n* Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia.\n* Patients who do not consent to participate in the study.",{"count":97,"type":20},63,"INTERVENTIONAL",[100],"NA","The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid) delivered as a gel and a mouthwash is to be studied in regard to its effect on the incidence of severe oral mucositis in Head \\& Neck cancer radiated patients. Patient reported outcome measures seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients, being used in this study to assess quality of life of Head \\& Neck cancer radiated patients.",[24,25,26,27,28,29,30,31,103],"Head and Neck Cancer",[24,33,34,27,35,36,37,38,39,103,105],"Severe Oral Mucositis","RECRUITING","2026-04-10",{"date":109,"type":44},"2026-04-15",{"date":111,"type":44},"2022-10-11",{"date":113,"type":20},"2027-03",{"name":50,"class":51},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":60,"minAge":61,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":98,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":52},"100590048","changes-in-the-impact-of-genitourinary-syndrome-of-menopause-with-a-novel-nonhormonal-vulvovaginal-gel-assessed-by-proms-100590048","NCT06962345","Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.","Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial. Part of STOP GSM PROJECT.","STOPGSMP","Inclusion Criteria:\n\n* Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15).\n* Patient must be postmenopausal with at least 1 year without a menstrual period.\n* Patient must consider that her quality of life is affected by GSM symptoms\n* Patient not followed due to any gynecological disease.\n* All participants must be able to understand and to fill in the self-reported questionnaires.\n\nExclusion Criteria:\n\n* Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning.\n* Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies for GSM, including topical vaginal non-hormonal lubricants or moisturizers for the last week.\n* Patients with history of vulvar, vaginal and\u002For cervical malignancy.\n* Patients having received radiotherapy treatment in the pelvic and\u002For genital region.\n* Patients with any type of disease that causes alteration of collagenogenesis.\n* Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months.\n* Patients having received laser and\u002For radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions.\n* Patients with active urinary and\u002For genital tract infection.\n* Patients with history of malignant neoplasm of the urinary system.\n* Patients with severe stress urinary incontinence (Sandvik test score equal to or greater than 8).\n* Patients with diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification.\n* Patients with medical or surgery history that, at the investigator's discretion, does not allow participation in the study.\n* Patients with any other condition that, at the investigator's discretion, implies that the patient is unable to understand the implication of participating in the study and\u002For following the established procedures.","70 Years",{"count":125,"type":20},80,[100],"The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.",[67,68,77,25,70,71,72,73,74,75],[77,68,78,25,79,74],"2026-03-25",{"date":132,"type":44},"2026-03-30",{"date":134,"type":44},"2024-01-08",{"date":136,"type":20},"2026-12",{"name":50,"class":51},""]